Binding of Lu AG06466 in the Brain in Healthy Men

Healthy Clinical Trial

Official title:

Interventional, Open-label, Position Emission Tomography (PET) Study Investigating MAGL Occupancy After Single and Multiple Oral Doses of Lu AG06466 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04419636
• Other study ID #: 18454A
• Status: Completed
• Phase: Phase 1
• Start date: May 29, 2020
• Est. completion date: February 16, 2021

Study information

• Verified date: February 2021
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to learn how Lu AG06466 and one of its break down products binds in the brain after single and repeated dosing

Description:

The study will be conducted in two Parts. Part A: cross over, fed/fasted determined by randomized sequence Part B: sequential group

PET scans will be used to quantify MAGL occupancy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 16, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• body weight =60 kg.

• body mass index =18.5 and =27 kg/m2.

• waist circumference =94 cm.

• The subject has a normal sMRI performed during the screening period.

• The subject is suitable for radial artery blood sampling and cannulation as demonstrated by the Allen test.

• Subject must be healthy as assessed using detailed medical history, laboratory tests, and physical examination.

• The subject must make use of contraception.

Exclusion Criteria:

• The subject is left handed.

Other in- and exclusion criteria may apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lu AG06466
capsules, orally

Locations

Country	Name	City	State
Belgium	UZ Leuven campus Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central monoacylglycerol lipase (MAGL) occupancy		From dosing to 8 hours post-dose
Secondary	C(PET)	Average plasma concentration for Lu AG06466 and Lu AG06988 during PET imaging	From zero to Day 10
Secondary	AUC (0-24)	Area under the plasma concentration curve for Lu AG06466 and Lu AG06988 from zero to 24 hours	From zero to 24 hours post-dose
Secondary	Cmax	Maximum observed plasma concentration for Lu AG06466 and Lu AG06988	From zero to 24 hours post-dose